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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lens, contact (other material) - daily
510(k) Number K183167
Device Name Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens
Applicant
Bausch & Lomb, Incorporated
1400 North Goodman Street
Rochester,  NY  14609
Applicant Contact Glenn A. Davies
Correspondent
EyeReg Consulting Inc.
6119 Canter Lane
West Linn,  OR  97068
Correspondent Contact Bret James Andre
Regulation Number886.5916
Classification Product Code
HQD  
Date Received11/15/2018
Decision Date 02/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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